Prohormones 2018: A DASCA Refresher

Prohormones 2018: A DASCA Refresher

As most of you remember, in December of 2014 then-President Barack Obama signed the Designer Anabolic Steroid Control Act of 2014 (DASCA). The DASCA replaced two prior versions of the Anabolic Steroid Control Act (ASCA) that were passed in 1990 and 2004, respectively. Congress intended the DASCA to erase the distinction between the substances once called “prohormones” (steroidal substances unlawfully marketed as dietary supplement products that were either precursors of traditional anabolic steroids or steroidal substances that weren’t specially listed in the ASCA) and the substances that were traditionally regarded as anabolic steroids (testosterone, nandrolone, trenbolone, boldenone, etc.). The DASCA replaced the previous Anabolic Steroid Control Acts of 1990 and 2004 and is now the primary law covering distribution and possession of all types of anabolic steroids. If a substance meets the criteria of the DASCA, then by definition it’s an anabolic steroid even if it is not specifically listed in the law. The DASCA says that:

a drug or hormonal substance (other than estrogens, progestins, corticosteroids, and dehydroepiandrosterone) that is not listed … and is derived from, or has a chemical structure substantially similar to, 1 or more [listed] anabolic steroids [is considered an anabolic steroid] if … [it] has been created or manufactured with the intent of [promoting muscle growth or having pharmacological effects like testosterone or] has been, or is intended to be, marketed or otherwise promoted [to suggest it will promote muscle growth or have pharmacological effects like testosterone].

In other words, derivatives and slight variations of explicitly listed compounds can fall within the DASCA if they are made, marketed, or intended to be marketed, to build muscle or have other effects like testosterone.

Prior to the DASCA, most prohormone prosecutions were brought against industry companies as crimes under FDA law – typically, the felony of introducing a misbranded drug into interstate commerce with the intent to defraud and mislead FDA. That’s the same law used to prosecute those fraudulently selling peptides or active pharmaceutical ingredients for “research purposes only.” Prohormones can still be prosecuted under the FDA law, which targets marketers and sellers. However, the DASCA permits the Attorney General to take action against both industry and consumers by scheduling new compounds as controlled substances. The DASCA contains exemptions, which have apparently created a bit of confusion in Congress. On its face, the law exempts a compound if it is: (1) “an herb or other botanical” or “a concentrate, metabolite, or extract of, or a constituent isolated directly from, an herb or other botanical” or “a combination of 2 or more” such substances; (2) a dietary ingredient (under DSHEA) and (3) “not anabolic or androgenic.” That’s three separate criteria and all three must be met for exemption. However, it seems that some members of Congress may have not carefully read their own legislation. In its Summary1, Congress says the law exempts a substance if it is: “(1) an herb or other botanical, a concentrate, metabolite, or extract of, or a constituent isolated directly from, an herb or other botanical, or a combination of two or more such substances; or (2) a dietary ingredient [under the Dietary Supplement Health and Education Act (DSHEA), the federal dietary supplement law] and is not anabolic or androgenic.” The variation in the language of the Summary changes the exemption rules. One difference is that the Summary exempts ANY dietary ingredients if they aren’t anabolic or androgenic, not just herbal or botanical ones. Another distinction is that the Summary would also exempt ALL botanicals from the law, even those that are anabolic or androgenic. Maybe it makes no practical difference in the real world but ensuring that any Summary of the law actually parallels the three separate criteria of the law itself is important, especially when we have had two previous less than successful attempts by Congress at a comprehensive steroid control law.

If you’re in the supplement industry and want to better understand the DASCA, DSHEA, or other federal laws and regulations affecting natural products, please call my law firm at 516-294-0300 for a consultation or arrange to speak with us at the Olympia Expo, Supply Side West, the Arnold Sports Festival, or Natural Products Expo West or East.

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Rick is passionate in the defense of his clients, and works diligently as lead counsel, co-counsel, or as a steroid, bodybuilding drug or PED
consultant with lawyers throughout America and even internationally.